Junior Medical Writer
- Belgium

Ablynx (company)

Project Description

Job Description

Work and interact extensively with internal subject matter experts and external contacts within crossfunctional teams for the preparation of high quality clinical, regulatory and scientific documents. High quality refers to scientific content, organization, clarity, accuracy, format, and compliance with regulatory and internal guidelines, styles and processes..

Key Responsibilities

Writing, reviewing and editing of technical documents including but not limited to:

Clinical study protocols

Clinical study reports

Investigator Brochures

Clinical summaries and overviews

Investigational New Drug applications

Clinical Trial Applications

Scientific advice briefing documents

Pediatric Investigation Plans

Orphan Drug applications

Risk Management Plans

Clinical parts of Marketing Authorization Applications

Presentations to support discussion meetings in the context of all the above

Clinical/scientific content for Ablynx websites

Ensuring that the completed documents are accurate, in line with approved format, and compliant with applicable external and internal guidelines.

Working with external vendors for the coordination, review and finalization of any outsourced document writing activities

Publishing of clinical study protocol and trial results data on external databases as per regulatory requirements

Developing and maintaining document templates

Enabling process improvement initiatives through sharing of best practices

Contributing to development of processes, including preparation of standard operating procedures

Skills, expertise and contribution

Mastery of the English language, particularly written

Excellent writing skills, ability to extract key messages from complex datasets and present these in a clear and accurate way

Scientific background enabling thorough understanding of content to be written

Awareness of regulatory environment for clinical trials in EU, US and other regions, particularly with respect to requirements applicable to (clinical) regulatory documents with respect to content, level of detail, format, etc., including requirements for electronically submitted documents (e.g. eCTD)

Computer knowledge. Proficient in Windows and MS Office (Word, Excel, Powerpoint), publishing and document management tools. Is able to solve any such problems that might occur with respect to document formatting or publishing either directly or through interaction with IT, software vendors or consultancy providers

Ability to manage multiple and varied tasks and prioritize workload with attention to detail and while maintaining agreed timelines

Ability to work under time pressure to achieve goals within set timelines while maintaining quality

Team Player

Organizational and planning skills

Communication skills

Conflict handling and problem solving

Detail oriented, methodical and goal driven

Being accountable: exercising judgment/impact of decisions/consequence of error

Minimum Qualifications

Expected experience: Minimum of 3 years of relevant experience in (Clinical) Research and Development within the pharmaceutical or biopharmaceutical industry.

Job Grading

Job grading and career progression as Medical Writer will depend on the magnitude of the job as measured via the job grading tool (Hewitt) as well as via the overall impact by the individual on the team, department or company. The job grading will be evaluated based on 5 criteria as described in the above: Knowledge & Application, Problem solving & Innovation, Interaction, Impact and Accountability. Individual impact will be determined by factors such as Experience, Informal leadership, Performance, Job management & competences versus current job description and the individual’s Critical value. The overall assessment will lead to the band and/or level of the Medical Writer.

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